C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 5CM; INTRODUCER, CATHETER
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Model Number N/A |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2022, the patient underwent picc puncture and catheterization for continuous chemotherapy.During the puncture process, the puncture needle was successfully punctured into the blood vessel, and the guide wire was put into it.When it was ready to be sent into the vascular sheath, because the end of the guide wire had a barb, the vascular sheath could not pass through the guide wire to complete the delivery of the vascular sheath into the blood vessel.The end of the guide wire is trimmed with sterile scissors in the bag before feeding into the vascular sheath.The patient was not affected, but the normal course of the procedure was affected.
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Manufacturer Narrative
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The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number provided by the complainant is invalid.
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